Effects of rTMS on the Cognition of Elderly With Mild Memory Complaints (TMSMemOld)

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ClinicalTrials.gov Identifier: NCT01292382

Recruitment Status : Unknown

Verified August 2010 by University of Sao Paulo General Hospital. Recruitment status was: Recruiting

Memory is constituted by a set of mental abilities of information processing that will be available at a later time. Flawless performance depends on several brain systems and other cognitive domains. Normal aging is characterized by cognitive deficits that may worsen the production capacity and quality of life. Such deficits represent variations of normal , and may stabilize,or even better progress. Include multiple cognitive domains, such as working and episodic memory, and attention. Despite the heterogeneity of the nature and severity of these deficits, common characteristics were observed in neuropsychological assessment of that population, for example, reduction in processing speed. There is an important gap in the therapeutic approach of these individuals.

Transcranial magnetic stimulation (TMS) is a noninvasive and promising intervention, with potential to improve memory and cognition activating networks that operate on memory or other networks that interfere with cognitive performance. The technique relies on generating a variable magnetic field originated from an alternating electric current applied to the human skull reaching focal cortical regions.

This study is a sham-controlled clinical trial, randomized, double-blind study. It will be evaluated the effects of repetitive transcranial magnetic stimulation (rTMS) on global cognition (memory, attention, language, executive functions, planning, logical reasoning, calculation and visual-spatial perception), especially memory, of elderly individuals with mild cognitive impairment, included in the domain of cognitive impairment no dementia (CIND).

Condition or disease

Intervention/treatment

Phase

Mild Cognitive Impairment

Device: Repetitive transcranial magnetic stimulation

Not Applicable

Detailed Description:

Subjects:

I. Eligibility criteria:

Male and female participants

Older adults aged 60-74 years

Education ≥ 4 years

Performance on neuropsychological tests below normal for age and education

Availability to attend the sessions of the application of TMS and neuropsychological assessments

Signing an informed consent by the participant or his guardian

II. No eligibility criteria:

Prior diagnosis of dementia

Any psychiatric disorder, except for mild depression in remission for at least 6 months. Shall be excluded those with scores > 12 on the Hamilton Depression Scale

History of neurosurgery and implantation of metal clips, head trauma, implantation of cardiac pacemakers, stroke, transient ischemic attack, cardiac surgery

Severe uncontrolled organic disease that might interfere with the conduct of the study, such as cancer, congestive heart disease, digestive disorders, diabetes mellitus type I or type II, dyslipidemia etc.

Sensory impairments(to guarantee a adequate performance in the tests to evaluate cognitive functions)

Magnetic resonance imaging of the brain with evidence of lacunar or large vessels infarctions, cerebral hemorrhage

13. Hachinski Ischemic score of > 7 (or modified by Loeb > 5) 14. Any other condition that in the opinion of the investigator becomes problematic inclusion of the patient in a trial of this nature, as well as patients who do not adhere or do not cooperate.

III. Outcome measures:

Will be considered as an outcome measure a variation greater than or equal to 10% compared to baseline scores of neuropsychological tests, which will be applied on three occasions: immediately before (T0), after treatment (T2) and 4 weeks after the end of it (T3).

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Ages Eligible for Study:

60 Years to 74 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Participants of both sexes

Aged between 60 and 74 years

Schooling ≥ 4 years

Performance on neuropsychological tests of up to 1.5 standard deviations below normal for age and education

Signing an informed consent by the participant or his guardian.

Exclusion Criteria:

Prior diagnosis of dementia.

Any psychiatric disorder, except for mild depression for at least six months.

Shall be excluded those with scores> 12 on the Hamilton scale.

History of neurosurgery and implantation of metal clips, head trauma, implantation of cardiac pacemakers, stroke, transient ischemic attack, cardiac surgery

Clinical or neurological diseases with an impact on cognitive ability

Neurodegenerative central nervous system (eg Parkinson's disease)

Alcohol and other drug dependency with abstinence for less than a year

Severe uncontrolled organic disease that could interfere in the conduct of the study, such as cancer, heart disease, digestive disorders, diabetes mellitus type I or type II, uncontrolled dyslipidemia etc.